Spots Global Cancer Trial Database for A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
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Trial Identification
Brief Title: A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
Official Title: An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics, and Efficacy of BI 754091 in Patients With Advanced Solid Tumours
Study ID: NCT02952248
Conditions
Interventions
Study Description
Brief Summary: The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as changes to vital signs. Secondary objectives are the determination of the PK profile of BI 754091 after single and multiple doses of BI 754091, and the preliminary assessment of antitumour activity. In the dose-expansion part of the trial, the main objectives are to further assess the safety, efficacy, PK profile, and biomarkers of BI 754091 in tumours with specific tumour types and/or genetic mutations at the RP2D.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Florida Cancer Specialists, Sarasota, Florida, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Greenville Health System, Greenville, South Carolina, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Juravinski Cancer Centre - Hamilton Health Sciences, Hamilton, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
Sarah Cannon Research Institute, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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